First it was Lead in toys. Then it was fake protein in Dogfood.
Then came the case of the contaminated heparin: A much scarier and sophisticated scam since it wasn’t the result of cutting corners but required someone with knowledge of chemistry and American drug quality testing techniques to detect the cheaper fake ingredient.
Well, the good news is that there is now a cheap and easy test to detect the chemical that contaminated heparin. But now, reports are surfacing about generic drugs, many mandated by HMO’s or insurance companies, may now come from countries without adequate quality control.
Last week the Washington Post had an excellent summary of the problem, which includes not only buying the drugs from overseas companies, but pointing out that US companies may manufacture drugs from ingredients bought from third world countries that don’t have adequate supervision.
The countries in question are mainly India and China. Both have a growing economy, and both have both the expertise and the ingredients to cheaply manufacture drugs.
But the dirty little secret is that both countries (like the Philippines) have had problems with quality control, and the FDA has little or no presence there to guarantee there are no problems in the manufacture of the drugs.
Or, as the article puts it:
Hubbard and other experts agree that many Indian and Chinese drugmakers are high-quality firms that provide products at a fraction of the price charged by American and European manufacturers. But, they add, Indian and Chinese companies are not only new to the FDA standards, but they also are in nations that have recent histories of widespread drug counterfeiting, lax quality control and very limited government regulation.
That last part, about drug counterfeiting, was the problem with the contaminated blood thinner (Heparin). As I had written in earlier reports, it was a criminal act, not a quality control problem.
And the real killer is not medicine that is slightly substandard, but medicines that are deliberately counterfeited or adulterated to make huge profits for criminal elements.
The UK Guardian quotes the World Health Organization that counterfeit or substandard medicine causes 20 percent of Malaria deaths, an estimated 200 thousand people dying each year so that criminals in the drug fakery business can make a profit.
Up to 50% of the drugs sold in Asia and Africa are fakes, in a trade estimated by the US Food and Drug Administration to be worth between $35bn and $44bn (Â£18.5bn-Â£23.1bn) annually.
And much of this, especially from China, has been linked to criminal elements who can bribe officials, launder money, and smuggle the drugs to be sold elsewhere. (The Chinese government has persecuted several officials for taking such bribes so I am not accusing them of being lax, only pointing out that the criminals of a large country can easily stay one step ahead of poorly funded government officials).
In the case of the counterfeit anti Malaria medicine, things are worse: Not only do people die, but since often the pills contain small amounts of the drug in question, so that the organism becomes resistant to the drug over time.
Some of this resistance of germs due to undertreatment, because people can’t afford the full dose of medicine or because patients don’t take all their medicine, or self medicate and use the wrong dose.
But another problem is that the counterfeit pill may only contain a small amount of the medicine.
The Daily Trust (Abuja Nigeria) reports
Dr. Lawal Abdulrahman, who works in private hospital in Abuja, explained that several factors are responsible for the increased resistance of malaria to drugs. One factor he identified is the presence of fake drugs in the country.
According to the PLoS Medicine study, “most of the fakes examined as part of Operation Jupiter contained no artesunate, and some contained a wide range of potentially toxic active ingredients. Also of grave concern was the fact that counterfeiters sometimes included dangerously small amounts of artesunate in the tablets. This may be done to foil screening tests of drug quality, but these doses are too low to be efficacious, yet high enough to contribute to malaria parasites becoming resistant to this class of drugs.”
It is this small amount of artesunate found in fake drugs, according to Dr. Paul Newton of the University of New York, that has led to increased resistant of the disease to the malaria parasite
Do we have this problem in the Philippines?
Well, luckily we don’t have malaria here, but my relatives who are still in practice says fake and substandard generic medications are a major problem, which is why they oppose the government’s plan to mandate generic drugs here.
I’ll give you and example of our experience here.
When we first moved to the Philippines, my elderly husband had an infected toe. I put him on a generic antibiotic, but after five days there was no improvement, so I sent a note to our niece, a physician, asking if we had MRSA and needed to change antibiotics. When she found the antibiotic was generic, she gave me a lecture, and promptly switched him to a well know brand name of the same antibiotic. Two days later, the infection was improved, and in five days it was better.
Was the antibiotic fake? was the antibiotic substandard? Or did the infection just happen to get better after five days from coincidence?
Whatever. All I know is that now I only order brand name medicines for severe infections.